Status:
RECRUITING
Analysis of Urinary Methylation Patterns Via Liquid Biopsy as an Early Diagnosis Tool
Lead Sponsor:
Regina Elena Cancer Institute
Collaborating Sponsors:
Azienda Ospedaliera Santa Maria Degli Angeli
Istituto per lo Studio, la Prevenzione e la Rete Oncologica
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Brief Summary
Multicenter, observational, prospective, biological pilot study on liquid biopsy, aimed at investigating methylation profiles in relation to the early diagnosis of bladder cancer, to validate the pote...
Detailed Description
The study has the primary objective to investigate the diagnostic capacity of methylation levels in urine samples, furthermore it has the secondary objective of applying an NGS test on the urine sampl...
Eligibility Criteria
Inclusion
- Patient group
- age ≥ 18 years
- proven diagnosis of bladder cancer (infiltrating muscle or non-infiltrating muscle)
- performance status (PS) 0-1
- ability to follow the procedures established by the study
- written consent for participation in the study and data processing
- group of healthy subjects
- age ≥ 18 years
- ability to follow the procedures established by the study
- written consent for participation in the study and data processing
Exclusion
- Patient group
- presence of metastatic bladder cancer
- lack of autonomy in following the procedures established by the study
- group of healthy subjects
- previous or current clinical history associated with bladder cancer
- diagnostic suspicion associated with tumor pathologies
- ongoing or previous systemic oncological treatments
- presence of inflammatory and/or autoimmune diseases related to particular conditions potentially modifying the methylation profile
- existing pharmacological treatments (and/or any other type of treatment) that could alter the results of the analyzes conducted for the present study
- lack of autonomy in following the procedures established by the study
Key Trial Info
Start Date :
August 6 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 6 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06878027
Start Date
August 6 2024
End Date
February 6 2026
Last Update
March 14 2025
Active Locations (1)
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1
IRCCS National Cancer Institute "Regina Elena"
Rome, Italy, 00144